RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information.

About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

New: Take the RAC Exam Online

The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move
across top level links and expand / close menus in sub levels. Up and Down arrows will open main level
menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab
will move on to the next part of the site rather than go through menu items.

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

The RAPS store will be under maintenance Saturday, 13 June between 6 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

As part of a bid to bring down the price of pharmaceuticals in the US, Reps. Jan Schakowsky (D-IL), Keith Ellison (D-MN), Rosa DeLauro (D-CT) and 33 other House members sent a letter to President Donald Trump on Monday seeking a way forward to meet the promises he’s made on the campaign trail and since taking office.

Among the suggestions is to attach drug price lowering provisions to the bill reauthorizing the US Food and Drug Administration (FDA) user fee agreements, which advanced in the Senate last week and has so far largely remained non-political.

"There is no shortage of possible reforms for us to pursue in the context of the UFAs [user fee agreements]," the representatives wrote. "For example, we could require Medicare to negotiate for the price of drugs, as you have called for. We can work to improve transparency around drug pricing so we can better understand how much drug corporations spend to develop and manufacture their drugs and how much they make in profits from those drugs."

Other examples of add-ons to the legislation proposed by the group include ensuring "that generic drug manufacturers, whose products help to lower the costs of prescription drugs through competition, have access to the materials needed to conduct studies essential for FDA approval."

The group also floated an idea recently offered by Mick Mulvaney, Trump’s appointed director of the Office of Management and Budget, which would require drug companies to provide rebates to Medicare when the cost of their drug exceeds a certain threshold, as they currently do for drugs covered by Medicaid.

In addition to the letter, Sens. Amy Klobuchar (D-MN), John McCain (R-AZ), and Chuck Grassley (R-IA) urged Mulvaney to use "existing statutory authority to quickly restore competition to the market with the introduction of cheaper, imported alternatives," such as those from Canada.

Another group of bipartisan senators is also planning to reintroduce a bill tomorrow to require pharmaceutical companies to justify their prices and provide manufacturing, R&D and marketing costs. Industry groups like PhRMA have lobbied against such transparency bills recently.